Hypotonic aqueous composition with reduced chloride content, with or without phospholipids

Abstract

An aqueous composition for application in a method for surgical or therapeutic treatment of the human or animal body or in a diagnostic procedure which is practiced on the human or animal body, the composition comprising osmotically active particles and containing less than 70 μl −1 of amniotic cells, the osmolarity of the composition being in the range from 240.0 mosm/l to less than 308.0 mosm/l, and the chloride ion concentration in the composition being not more than 130.0 mmol/l. An aqueous composition for application with an amniotic infusion, the composition containing less than 70 μl −1 of amniotic cells and comprising at least one surfactant, is also disclosed.

The invention claimed is: 
     
       1. An aqueous composition for application in a method for the surgical or therapeutic treatment of the human or animal body or in a diagnostic method performed on the human or animal body, the aqueous composition consisting essentially of:
 (a) water, sodium ions, potassium ions, calcium ions, chloride ions, and hydrogencarbonate ions; and 
 (b) optionally at least one selected from the group consisting of magnesium ions, urea, uric acid, phosphate ions, glucose, lactate salts, citrate salts, copper ions, selenium ions, zinc ions, phospholipids, lipids, surfactant proteins, proteins, amniotic cells, and non-fetal DNA; 
 wherein:
 the composition contains fewer than 70 amniotic cells per μl, 
 an osmolarity of the composition is in the range from 240.0 mosm/l to less than 308.0 mosm/l, 
 a lactate salt concentration in the composition ranges from 0.0 mmol/l to 20.0 mmol/l, and 
 a chloride ion concentration in the composition is not more than 130.0 mmol/l. 
 
 
     
     
       2. The aqueous composition as claimed in  claim 1 , wherein the composition contains at least one phospholipid. 
     
     
       3. The aqueous composition as claimed in  claim 1 , wherein the composition contains at least one surfactant protein. 
     
     
       4. The composition as claimed in  claim 1 , wherein the composition contains at least one of (i) one or more phospholipids and (ii) one or more surfactant proteins. 
     
     
       5. The composition as claimed in  claim 1 , wherein the composition contains at least one phosphatidylcholine. 
     
     
       6. The composition as claimed in  claim 5 , wherein a weight fraction of phosphatidylcholine, based on all lipids, is greater than 50.0% by weight. 
     
     
       7. The composition as claimed in  claim 1 , wherein the composition contains sphingomyelin. 
     
     
       8. The composition as claimed in  claim 7 , wherein a weight ratio of phospholipids to sphingomyelin is greater than 1.5. 
     
     
       9. The composition as claimed in  claim 3 , wherein a weight fraction of all surfactant proteins, based on the total weight of the composition, is greater than 1.0 mg/l. 
     
     
       10. The composition as claimed in  claim 2 , wherein a weight fraction of all phospholipids, based on the total weight of the composition, is greater than 120.0 mg/l. 
     
     
       11. The composition as claimed in  claim 1 , wherein the osmolarity of the composition is in the range from 240.0 mosm/l to 300.0 mosm/l. 
     
     
       12. The composition as claimed in  claim 11 , wherein a calcium ion concentration in the composition is in the range from 1.0 mmol/l to 2.5 mmol. 
     
     
       13. A combination comprising the individual components of a composition as claimed in  claim 1  in at least two different fractions. 
     
     
       14. The composition as claimed in  claim 4 , wherein the osmolarity of the composition is in the range from 240.0 mosm/l to 300.0 mosm/l. 
     
     
       15. The composition as claimed in  claim 14 , wherein a calcium ion concentration in the composition is in the range from 1.0 mmol/l to 2.5 mmol. 
     
     
       16. A combination comprising the individual components of a composition as claimed in  claim 4  in at least two different fractions. 
     
     
       17. A method for performing amnioinfusion, the method comprising infusing the aqueous composition according to  claim 1  into an amniotic cavity of a human or an animal patient. 
     
     
       18. A method for performing amnioinfusion, the method comprising: infusing the aqueous composition according to  claim 1  into an amniotic cavity of a human or an animal patient to maintain a normal fluid volume in the amniotic cavity of the patient. 
     
     
       19. A method for performing amnioinfusion, the method comprising continuously infusing the aqueous composition according to  claim 1  into an amniotic cavity of a human or an animal patient. 
     
     
       20. A method for performing amnioinfusion, the method comprising continuously infusing the aqueous composition according to  claim 1  into an amniotic cavity of a human or an animal patient for a period of at least 30 minutes. 
     
     
       21. A method for performing amnioinfusion, the method comprising infusing the aqueous composition according to  claim 1  into an amniotic cavity of a pregnant human or a pregnant animal patient to treat preterm premature rupture of membranes in the patient. 
     
     
       22. The method of  claim 21 , wherein the patient is a human patient between week 13 of pregnancy and week 40 of pregnancy. 
     
     
       23. A method for performing amnioinfusion, the method comprising infusing the aqueous composition according to  claim 1  into an amniotic cavity of a pregnant human or a pregnant animal patient to expedite lung maturation of a fetus in the pregnant patient, wherein the aqueous composition further comprises at least one surfactant. 
     
     
       24. A method for treating a patient, the method comprising rinsing a body cavity or region of a human or an animal patient with the aqueous composition according to  claim 1 . 
     
     
       25. A method for performing amnioinfusion, the method comprising infusing the aqueous composition according to  claim 4  into an amniotic cavity of a human or an animal patient. 
     
     
       26. A method for performing amnioinfusion, the method comprising infusing the aqueous composition according to  claim 4  into an amniotic cavity of a human or an animal patient to maintain a normal fluid volume in the amniotic cavity of the patient. 
     
     
       27. A method for performing amnioinfusion, the method comprising continuously infusing the aqueous composition according to  claim 4  into an amniotic cavity of a human or an animal patient. 
     
     
       28. A method for performing amnioinfusion, the method comprising continuously infusing the aqueous composition according to  claim 4  into an amniotic cavity of a human or an animal patient for a period of at least 30 minutes. 
     
     
       29. A method for performing amnioinfusion, the method comprising infusing the aqueous composition according to  claim 4  into an amniotic cavity of a pregnant human or a pregnant animal patient to treat preterm premature rupture of membranes in the patient. 
     
     
       30. The method of  claim 29 , wherein the patient is a human patient between week 13 of pregnancy and week 40 of pregnancy. 
     
     
       31. A method for performing amnioinfusion, the method comprising infusing the aqueous composition according to  claim 4  into an amniotic cavity of a pregnant human or a pregnant animal patient to expedite lung maturation of a fetus in the pregnant patient, wherein the aqueous composition further comprises at least one surfactant. 
     
     
       32. A method for treating a patient, the method comprising rinsing a body cavity or region of a human or an animal patient with the aqueous composition according to  claim 4 . 
     
     
       33. The aqueous composition as claimed in  claim 1 , wherein the aqueous composition consists of:
 (a) water, sodium ions, potassium ions, calcium ions, chloride ions, and hydrogencarbonate ions; and 
 (b) optionally at least one selected from the group consisting of magnesium ions, urea, uric acid, phosphate ions, glucose, lactate salts, citrate salts, copper ions, selenium ions, zinc ions, phospholipids, lipids, surfactant proteins, proteins, amniotic cells, and non-fetal DNA. 
 
     
     
       34. The aqueous composition as claimed in  claim 1 , wherein the aqueous composition contains one or more proteins selected from the group consisting of albumin, apoprotein B, lipoprotein, and combinations thereof. 
     
     
       35. The aqueous composition as claimed in  claim 1 , wherein the aqueous composition contains one or more surfactant proteins selected from the group consisting of surfactant protein A, surfactant protein B, surfactant protein D, and combinations thereof. 
     
     
       36. The aqueous composition as claimed in  claim 1 , wherein the aqueous composition contains one or more lipids selected from the group consisting of cholesterol, saturated fatty acids, unsaturated fatty acids, and combinations thereof. 
     
     
       37. The aqueous composition as claimed in  claim 1 , wherein the aqueous composition contains one or more phospholipids selected from the group consisting of phosphatidylcholine, dipalmitoylphosphatidylcholine, palmitoylmyristol-phosphatidylcholine, phosphatidylglycerol, phosphatidylethanolamine, phosphatidylinositol, phosphatidylserine, sphingomyelin, lysophospholipid, and combinations thereof. 
     
     
       38. The aqueous composition as claimed in  claim 1 , wherein the composition is in the form of a single fraction including the components of the composition. 
     
     
       39. The aqueous composition as claimed in  claim 1 , wherein:
 the osmolarity of the composition is in the range from 240.0 mosm/l to 280.0 mosm/l, 
 the chloride ion concentration in the composition is in the range from 105.0 mmol/l to 115.0 mmol/l, 
 a sodium ion concentration in the composition is less than 150.0 mmol/l, 
 a potassium ion concentration in the composition is in the range from 3.5 mmol/l to 4.5 mmol/l, 
 a calcium ion concentration in the composition is in the range from 1.5 mmol/l to less than 2.3 mmol/l, 
 a magnesium ion concentration in the composition is in the range from 0.1 mmol/l to less than 0.8 mmol/l, 
 a phosphate ion concentration in the composition is in the range from 0.1 mg/dl to 7.0 mg/dl, 
 a citrate salt concentration in the composition is in the range from 0.0 mg/l to 100.0 mg/l, 
 a hydrogencarbonate ion concentration in the composition is in the range from 10.0 mmol/l to 20.0 mmol/l, 
 a copper ion concentration in the composition is in the range from 5.0 μg/dl to 50.0 μg/dl, 
 a zinc ion concentration in the composition is in the range from 5.0 μg/dl to 25.0 μg/dl, and 
 a pH of the composition is in the range from 7.5 to 8.5.